The S-ICD System™ from Cameron Health, Inc., and Boston Scientific Corporation presents a new opportunity in cardiac rhythm management to reduce the complications associated with transvenous defibrillator systems. The defibrillator system itself may be implanted subcutaneously without accessing the vasculature or touching the heart.
The first approved commercial version of the S-ICD System™ delivered approximately 80 Joules of energy for defibrillation therapy. To supply this amount of energy in a timely fashion over the life of the device, three high power capacitors and three batteries were used in the first approved S-ICD System™ devices. Enhancements to reduce the total energy required may allow for reduction in size by facilitating the use of smaller or fewer batteries and/or capacitors. In addition, it is desired to increase the already high likelihood of successful implantation as measured by the ability to convert induced ventricular fibrillation at implant using 65 Joule therapy (an imputed success rate of 96.5% was calculated in PMA P11042: FDA Summary of Safety and Effectiveness Data, available online at http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110042b.pdf). New and alternative defibrillation lead and electrode designs, as well as alternative implant tools and methods, may be useful to achieve these goals.